Perineal Tear Resulting From ChildbirthPeMWaCNCT05854888
Perineal Massage and Warm Compresses - RCT for Reduce Perineal Trauma During Labor
A study testing Perineal Massage and Warm Compresses (PeMWaC) in people with Perineal Tear Resulting From Childbirth, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The aim of this study is to evaluate the effect of a combined perineal massage and warm compresses intervention on the perineum integrity during second stage of labor. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Tear Resulting From Childbirth
- What is being tested?
- Perineal Massage and Warm Compresses (PeMWaC)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2019to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with 18 years or older
- Between 37 and 41 weeks of pregnancy
- Expected spontaneous vaginal birth
- Fetus in the cephalic presentation
- Able to provide informed written consent
Who cannot join
- Multiple pregnancy
- Meconial amniotic fluid
- Fetal distress
- Suspicion of fetal growth restriction
- Gestational hypertensive disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perineal Massage and Warm Compresses During Second Stage of Labor - Randomised Controlled Trial for Reduce Perineal Trauma
The aim of this study is to evaluate the effect of a combined perineal massage and warm compresses intervention on the perineum integrity during second stage of labor.
Read the detailed description
A single-centre, prospective, randomized controlled trial was conducted. Eligibility and informed consent to participate were checked once the woman was in established labor. Eligible participants were randomized at the second stage of labor. The trial intervention took place during the second stage of the spontaneous vaginal birth. Participants were randomized to one of the two groups, perineal massage and warm compresses on second stage of labor or control group (hands-on).
- Conditions
- Perineal Tear Resulting From Childbirth
- Being tested
- Perineal Massage and Warm Compresses (PeMWaC), Control Group (Hands-on)
- Keywords
- Perineum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal Massage and Warm Compresses (PeMWaC)Procedure or surgery
Perineal Massage was performed in the II Hodge Plan, between maternal contractions and regardless of maternal position. Warm Compresses were applied by the midwife between Hodge plans III and IV, during pushing and regardless of maternal position.
Control Group (Hands-on)Procedure or surgery
The midwife placed the index, middle, and little fingers of the non-dominant hand together on the child's occiput, with the palm facing the anterior region of the perineum, when the child's head was crowning. In this way, the expulsion was controlled, maintaining the flexion of the head. Simultaneously, the dominant hand was flattened and placed on the posterior region of the perineum, with the index finger and thumb, forming a "U", exerting pressure on the posterior region of the perineum during the crowning process. During the birth of the shoulders and the rest of the body, the dominant hand was kept in place, protecting the posterior region of the perineum.
| Study group | Role | What they receive |
|---|---|---|
| PeMWaC (Perineal Massage and Warm Compresses) | Experimental | In the second stage of labor, the midwife performed a soft perineal massage between 3 o'clock and 9 o'clock positions (U-shaped reciprocating motion) wearing sterile gloves and lubricated their hand with sterile lubricant. The massage lasted 10 minutes and the degree of downward pressure by the thumb was determined according to mothers' response. Perineal massage was established on the II Hodge Plan, between maternal contractions and regardless of maternal position. The women could adopted the birthing position they prefer. The application of warm compresses was performed by the midwife between the III and IV Hodge plans, during pushing and regardless of the mother's position. A metal jug filled with warm water (between 45° and 59°C) was used to soak the compresses, which were squeezed out before being gently placed on the perineum during contractions. Receives: Procedure: Perineal Massage and Warm Compresses (PeMWaC) |
| Control group (Hands-on) | Active comparator | The midwife placed the index, middle, and little fingers of the non-dominant hand together on the child's occiput, with the palm facing the anterior region of the perineum, when the child's head was crowning. In this way, the expulsion was controlled, maintaining the flexion of the head. Simultaneously, the dominant hand was flattened and placed on the posterior region of the perineum, with the index finger and thumb, forming a "U", exerting pressure on the posterior region of the perineum during the crowning process. During the birth of the shoulders and the rest of the body, the dominant hand was kept in place, protecting the posterior region of the perineum, while the non-dominant hand supported the infant's head, allowing external rotation and spontaneous birth of the shoulders. After both shoulders were removed, the midwife removed the dominant hand from the posterior perineum. Receives: Procedure: Control Group (Hands-on) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intact Perineum
Absence of tissue separation at any site, without vaginal tears or any other degree of perineal trauma)
Measured: up to 10 minutes after childbirth
First-degree perineal tear
Skin and vaginal tear
Measured: up to 10 minutes after childbirth
Second-degree perineal tear
Skin and muscle tear (posterior compartment)
Measured: up to 10 minutes after childbirth
OASIS
Obstetric anal sphincter injuries (Third-degree tears (injury of anal sphincter) and Fourth-degree tears (Injury of anal sphincter and the anal canal or rectum) without episiotomy
Measured: up to 10 minutes after childbirth
OASIS + episiotomy
Third and fourth degree tear with episiotomy
Measured: up to 10 minutes after childbirth
Episiotomy
without spontaneous perineal trauma or vaginal tears
Measured: up to 10 minutes after childbirth
Episiotomy and first degree tear
Episiotomy with spontaneous skin tear
Measured: up to 10 minutes after childbirth
Episiotomy and second degree tear
Episiotomy and spontaneous skin and muscle tear
Measured: up to 10 minutes after childbirth
OASIS with/without episiotomy
with and without episiotomy
Measured: up to 10 minutes after childbirth
Vaginal tears
only vaginal tear
Measured: up to 10 minutes after childbirth
Anterior Compartment tears
Without episiotomy or any other degree of perineal trauma
Measured: up to 10 minutes after childbirth
Secondary outcomes (8)
Admission to Neonatal Intensive Unit Care
Admission to Neonatal Intensive Unit Care
Measured: up to 2 hours after childbirth
Apgar 5 minutes
Apgar Score at 5 minutes (0-10) higher scores mean better outcome
Measured: 5 minutes after childbirth
Maternal satisfaction with intervention
Question about maternal satisfaction with intervention
Measured: 24 hours after childbirth
Recommend an intervention allocated to a friend
Question about whether women would recommend the intervention they received to a friend
Measured: 24 hours after childbirth
Female Sexual Function Index score
Female Sexual Function Index score (2-36) higher scores mean better outcome
Measured: 24 hours, 3 months and 6 months after childbirth
Pelvic Floor Dysfunction symptoms
Pelvic Floor Distress Inventory (0-300) higher scores mean worse outcome
Measured: 24 hours, 3 months and 6 months after childbirth
Maternal Pain
Numerical Pain score (0-10) higher scores mean worse outcome
Measured: 24 hours, 3 months and 6 months after childbirth
Breastfeeding
Exclusive breastfeeding
Measured: 24 hours, 3 months and 6 months after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Mar 2019
- Primary completion31 Dec 2020
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perineal Tear Resulting From ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study was a single-centre, prospective, randomized controlled trial. Eligibility and informed consent to participate were checked once the woman was in established labor. All participants signed an informed consent form and received a copy wherein the study was described in detail.Eligible participants were randomized at the second stage of labor.The trial intervention took place during the second stage of the spontaneous vaginal birth. Participants were randomized to one of the two groups, perineal massage and warm compresses on second stage of labor or control group (hands-on). The participants could adopt the birth position they preferred.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sílvia Leite Rodrigues, Universidade do Porto
- Investigators
- Sílvia Rodrigues, PhD, Principal investigator, Institute Biomedical Sciences Abel Salazar-University of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854888
- Sponsor's protocol ID
- 201802476
- Acronym
- PeMWaC
- Status last verified
- May 2023
- First submitted
- 23 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Rodrigues S, Silva P, Esperanca M, Silva JN, Escuriet R. Effect of Perineal Massage and Warm Compresses Technique in Postpartum Perineal Pain. A Secondary Analysis from a Randomised Controlled Trial. Reprod Sci. 2026 Sep 15. doi: 10.1007/s43032-026-02204-6. Online ahead of print.
PubMed 42745022Rodrigues S, Silva P, Borges AC, de Sousa NQ, Silva JN, Escuriet R. Effect of Perineal Massage and Warm Compresses Technique in Postpartum Pelvic Floor Dysfunction. A Secondary Analysis from a Randomised Controlled Trial. Reprod Sci. 2024 Apr;31(4):1006-1016. doi: 10.1007/s43032-023-01424-4. Epub 2023 Dec 14.
PubMed 38097899
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineal Massage and Warm Compresses During Second Stage of Labor - Randomised Controlled Trial for Reduce Perineal Trauma
- ClinicalTrials.gov ID
- NCT05854888
- Acronym / sponsor ID
- PeMWaC / 201802476
- Conditions
- Perineal Tear Resulting From Childbirth
- Keywords
- Perineum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effect of a combined perineal massage and warm compresses intervention on the perineum integrity during second stage of labor.
Detailed description
A single-centre, prospective, randomized controlled trial was conducted. Eligibility and informed consent to participate were checked once the woman was in established labor. Eligible participants were randomized at the second stage of labor. The trial intervention took place during the second stage of the spontaneous vaginal birth. Participants were randomized to one of the two groups, perineal massage and warm compresses on second stage of labor or control group (hands-on).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study was a single-centre, prospective, randomized controlled trial. Eligibility and informed consent to participate were checked once the woman was in established labor. All participants signed an informed consent form and received a copy wherein the study was described in detail.Eligible participants were randomized at the second stage of labor.The trial intervention took place during the second stage of the spontaneous vaginal birth. Participants were randomized to one of the two groups, perineal massage and warm compresses on second stage of labor or control group (hands-on). The participants could adopt the birth position they preferred.
| Arm | Type | Receives |
|---|---|---|
| PeMWaC (Perineal Massage and Warm Compresses) | Experimental | Procedure: Perineal Massage and Warm Compresses (PeMWaC)In the second stage of labor, the midwife performed a soft perineal massage between 3 o'clock and 9 o'clock positions (U-shaped reciprocating motion) wearing sterile gloves and lubricated their hand with sterile lubricant. The massage lasted 10 minutes and the degree of downward pressure by the thumb was determined according to mothers' response. Perineal massage was established on the II Hodge Plan, between maternal contractions and regardless of maternal position. The women could adopted the birthing position they prefer. The application of warm compresses was performed by the midwife between the III and IV Hodge plans, during pushing and regardless of the mother's position. A metal jug filled with warm water (between 45° and 59°C) was used to soak the compresses, which were squeezed out before being gently placed on the perineum during contractions. |
| Control group (Hands-on) | Active comparator | Procedure: Control Group (Hands-on)The midwife placed the index, middle, and little fingers of the non-dominant hand together on the child's occiput, with the palm facing the anterior region of the perineum, when the child's head was crowning. In this way, the expulsion was controlled, maintaining the flexion of the head. Simultaneously, the dominant hand was flattened and placed on the posterior region of the perineum, with the index finger and thumb, forming a "U", exerting pressure on the posterior region of the perineum during the crowning process. During the birth of the shoulders and the rest of the body, the dominant hand was kept in place, protecting the posterior region of the perineum, while the non-dominant hand supported the infant's head, allowing external rotation and spontaneous birth of the shoulders. After both shoulders were removed, the midwife removed the dominant hand from the posterior perineum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women with 18 years or older
- Between 37 and 41 weeks of pregnancy
- Expected spontaneous vaginal birth
- Fetus in the cephalic presentation
- Able to provide informed written consent
Key exclusion criteria (5 listed)
- Multiple pregnancy
- Meconial amniotic fluid
- Fetal distress
- Suspicion of fetal growth restriction
- Gestational hypertensive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal Massage and Warm Compresses (PeMWaC)Perineal Massage was performed in the II Hodge Plan, between maternal contractions and regardless of maternal position. Warm Compresses were applied by the midwife between Hodge plans III and IV, during pushing and regardless of maternal position. | Procedure or surgery | PeMWaC (Perineal Massage and Warm Compresses) |
| Control Group (Hands-on)The midwife placed the index, middle, and little fingers of the non-dominant hand together on the child's occiput, with the palm facing the anterior region of the perineum, when the child's head was crowning. In this way, the expulsion was controlled, maintaining the flexion of the head. Simultaneously, the dominant hand was flattened and placed on the posterior region of the perineum, with the index finger and thumb, forming a "U", exerting pressure on the posterior region of the perineum during the crowning process. During the birth of the shoulders and the rest of the body, the dominant hand was kept in place, protecting the posterior region of the perineum. | Procedure or surgery | Control group (Hands-on) |
Primary outcome
Intact Perineum
Time frame: up to 10 minutes after childbirth
Absence of tissue separation at any site, without vaginal tears or any other degree of perineal trauma)
First-degree perineal tear
Time frame: up to 10 minutes after childbirth
Skin and vaginal tear
Second-degree perineal tear
Time frame: up to 10 minutes after childbirth
Skin and muscle tear (posterior compartment)
OASIS
Time frame: up to 10 minutes after childbirth
Obstetric anal sphincter injuries (Third-degree tears (injury of anal sphincter) and Fourth-degree tears (Injury of anal sphincter and the anal canal or rectum) without episiotomy
OASIS + episiotomy
Time frame: up to 10 minutes after childbirth
Third and fourth degree tear with episiotomy
Episiotomy
Time frame: up to 10 minutes after childbirth
without spontaneous perineal trauma or vaginal tears
Episiotomy and first degree tear
Time frame: up to 10 minutes after childbirth
Episiotomy with spontaneous skin tear
Episiotomy and second degree tear
Time frame: up to 10 minutes after childbirth
Episiotomy and spontaneous skin and muscle tear
OASIS with/without episiotomy
Time frame: up to 10 minutes after childbirth
with and without episiotomy
Vaginal tears
Time frame: up to 10 minutes after childbirth
only vaginal tear
Anterior Compartment tears
Time frame: up to 10 minutes after childbirth
Without episiotomy or any other degree of perineal trauma
8 secondary outcomes
Admission to Neonatal Intensive Unit Care
Time frame: up to 2 hours after childbirth
Apgar 5 minutes
Time frame: 5 minutes after childbirth
Maternal satisfaction with intervention
Time frame: 24 hours after childbirth
Recommend an intervention allocated to a friend
Time frame: 24 hours after childbirth
Female Sexual Function Index score
Time frame: 24 hours, 3 months and 6 months after childbirth
Pelvic Floor Dysfunction symptoms
Time frame: 24 hours, 3 months and 6 months after childbirth
Maternal Pain
Time frame: 24 hours, 3 months and 6 months after childbirth
Breastfeeding
Time frame: 24 hours, 3 months and 6 months after childbirth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 42745022Rodrigues S, Silva P, Esperanca M, Silva JN, Escuriet R. Effect of Perineal Massage and Warm Compresses Technique in Postpartum Perineal Pain. A Secondary Analysis from a Randomised Controlled Trial. Reprod Sci. 2026 Sep 15. doi: 10.1007/s43032-026-02204-6. Online ahead of print.
- Derived from this study: PubMed 38097899Rodrigues S, Silva P, Borges AC, de Sousa NQ, Silva JN, Escuriet R. Effect of Perineal Massage and Warm Compresses Technique in Postpartum Pelvic Floor Dysfunction. A Secondary Analysis from a Randomised Controlled Trial. Reprod Sci. 2024 Apr;31(4):1006-1016. doi: 10.1007/s43032-023-01424-4. Epub 2023 Dec 14.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
Related trials for Perineal Tear Resulting From Childbirth
Recruiting
Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma
Episiotomy, Lacerations Perineal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sílvia Rodrigues, PhD principal investigator
Institute Biomedical Sciences Abel Salazar-University of Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal Massage and Warm Compresses (PeMWaC) in people with Perineal Tear Resulting From Childbirth, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intact Perineum (time frame: up to 10 minutes after childbirth). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05854888, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.